Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-26 @ 12:24 AM
Study NCT ID:
NCT03295994
Status:
COMPLETED
Last Update Posted:
2025-03-30
First Post:
2017-09-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Operative Versus Non-Operative Treatment for Atraumatic Rotator Cuff Tears
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070636', 'term': 'Rotator Cuff Injuries'}], 'ancestors': [{'id': 'D012421', 'term': 'Rupture'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D000070599', 'term': 'Shoulder Injuries'}, {'id': 'D013708', 'term': 'Tendon Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 189}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-25', 'studyFirstSubmitDate': '2017-09-22', 'studyFirstSubmitQcDate': '2017-09-22', 'lastUpdatePostDateStruct': {'date': '2025-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Shoulder Pain & Disability Index (SPADI)', 'timeFrame': 'Study participants will be followed for 12 months', 'description': 'SPADI is a composite pain and function measure. The scale range is from 0 to 100, with 0 being best, and 100 being worst.'}], 'secondaryOutcomes': [{'measure': 'American Shoulder and Elbow Surgeons (ASES)', 'timeFrame': 'Study participants will be followed for 12 months', 'description': 'ASES is a pain and activity of daily living questionnaire. The range is from 0 to 100, with 0 being worst, and 100 being best.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['arthroscopy', 'physical therapy', 'rehabilitation', 'surgery', 'rotator cuff tear'], 'conditions': ['Rotator Cuff Tear']}, 'referencesModule': {'references': [{'pmid': '31397866', 'type': 'DERIVED', 'citation': 'Jain NB, Ayers GD, Koudelkova H, Archer KR, Dickinson R, Richardson B, Derryberry M, Kuhn JE; ARC Trial Group. Operative vs Nonoperative Treatment for Atraumatic Rotator Cuff Tears: A Trial Protocol for the Arthroscopic Rotator Cuff Pragmatic Randomized Clinical Trial. JAMA Netw Open. 2019 Aug 2;2(8):e199050. doi: 10.1001/jamanetworkopen.2019.9050.'}], 'seeAlsoLinks': [{'url': 'https://shoulderstudy.org/studies/arc-trial/', 'label': 'ARC Trial website'}]}, 'descriptionModule': {'briefSummary': 'Rotator cuff tears are one of the most common reasons to seek musculoskeletal care in the United States and one of the fastest growing ambulatory surgery procedures. However, data on comparison of operative versus non-operative treatment is lacking and urgently needed.', 'detailedDescription': 'This is non-blinded, randomized controlled trial. Patients will be randomly assigned to either an operative or non-operative course of treatment and will be followed for 12 months from baseline.\n\nAim 1: To compare pain and function in patients undergoing operative versus non-operative treatment of atraumatic rotator cuff tears at 12 months of follow-up\n\nAim 2: To assess effects of rotator cuff tear size and age on comparative outcomes of operative versus non-operative treatments for atraumatic rotator cuff tears\n\n5U34AR069201-02 NIH grant funded the preparatory work for the trial but not the trial itself.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '84 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged =\\>40 years to \\<85 years\n* Shoulder pain and/or loss of range of active motion, strength or function\n* MRI-confirmed partial- or full-thickness supraspinatus and/or infraspinatus tear of 4cm or less in longitudinal dimension\n* Medically fit for surgery, defined as Category I-III per American Society of Anesthesiologists (ASA) Physical Status Classification\n* Ability and willingness to provide informed consent\n\nExclusion Criteria:\n\n* Primary diagnosis is something other than a rotator cuff tear\n* History (in last 2 years) of shoulder fracture involving the humeral head on affected side\n* Previous rotator cuff surgery on affected side\n* Isolated subscapularis \\&/or teres minor tear on affected side\n* Acute rotator cuff tear caused by a severe trauma\n* Shoulder used as a weight-bearing joint\n* Contraindication to MRI (claustrophobia, pacemaker, pregnancy, shoulder implant, etc.)\n* Glenohumeral osteoarthritis on xrays/MRI, as determined by recruiting MD\n* Grade 4 fatty infiltration of rotator cuff (any tendons)\n* Candidate for shoulder arthroplasty at baseline\n* Non-English speaking'}, 'identificationModule': {'nctId': 'NCT03295994', 'acronym': 'ARC', 'briefTitle': 'Operative Versus Non-Operative Treatment for Atraumatic Rotator Cuff Tears', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Operative Versus Non-Operative Treatment for Atraumatic Rotator Cuff Tears: A Multicenter Randomized Controlled Pragmatic Trial', 'orgStudyIdInfo': {'id': '171863'}, 'secondaryIdInfos': [{'id': '1605-35413', 'type': 'OTHER_GRANT', 'domain': 'PCORI'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Operative', 'description': 'surgery + post-operative physical therapy', 'interventionNames': ['Procedure: Operative']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Non-Operative', 'description': 'non-operative physical therapy', 'interventionNames': ['Procedure: Non-Operative']}], 'interventions': [{'name': 'Operative', 'type': 'PROCEDURE', 'description': 'Arthroscopic rotator cuff surgery followed by physical therapy.', 'armGroupLabels': ['Operative']}, {'name': 'Non-Operative', 'type': 'PROCEDURE', 'description': 'Physical therapy (without surgery).', 'armGroupLabels': ['Non-Operative']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94158', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California - San Francisco (UCSF)', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Western Orthopaedics', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '80222', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado - Denver', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '40536', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Kentucky', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '21218', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02118', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48106', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '43202', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State University Wexner Medical Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Rothman Orthopaedic Institute', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '57105', 'city': 'Sioux Falls', 'state': 'South Dakota', 'country': 'United States', 'facility': 'Orthopedic Institute', 'geoPoint': {'lat': 43.54369, 'lon': -96.72796}}, {'zip': '37922', 'city': 'Knoxville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Ortho Tennessee - Knoxville Orthopedic Clinic', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Southwestern', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '23294', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Ortho Virginia', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}], 'overallOfficials': [{'name': 'Nitin Jain, MD,MSPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'collaborators': [{'name': 'Patient-Centered Outcomes Research Institute', 'class': 'OTHER'}, {'name': 'National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Physical Medicine & Rehabilitation, and Orthopaedics', 'investigatorFullName': 'Nitin Jain', 'investigatorAffiliation': 'University of Michigan'}}}}